Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was tested for genetic toxicity in three in vitro tests. In a bacterial reverse mutation assay, the substance was not mutagenic with or without S9 mix up to to 50 µg/mL (without S9 mix) or 15 µg/mL (with S9 mix), the highest dose-levels achievable regarding the severe cytotoxicity observed at higher dose-levels. It was also tested for mammalian cell gene mutations at the hprt locus on Chinese hamster Ovary (CHO) cells with and without metabolic activation and was not mutagenic in concentrations up to 20 µg/mL (based on the level of toxicity). In addition, the substance was tested in a chromosomal aberration test in human lymphocytes and was found not to be clastogenic up to 160 µg/mL (based on high level of toxicity observed at this dose-level) and despite equivocal results leading to second experiment. All tests were to current OECD/EU protocols carried out to GLP with a clearly defined and described test substance. Based on these results it can be concluded that N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) is not expected to be a genotoxic hazard to human health.


Justification for selection of genetic toxicity endpoint
For each endpoint bacterial mutagenicity, mammalian mutagenicity and mammalian clastogenicity one GLP compliant study is available.

Short description of key information:
N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was tested in three in vitro genotoxicity studies (bacterial reverse mutation test, mammalian chromosomal aberration test, mammalian cell gene mutation) to current protocol and carried out to GLP with well defined test substance. All three tests were negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Under the conditions of this study, the test substance was not considered to be mutagenic and as such, does not require classification according to Regulation EC No. 1272/2008 and Directive 67/548/EEC.